MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-18 for ISOLATION GOWN X-LARGE manufactured by Melco, Inc..
[20052147]
Isolation gowns found with a defect. Backs of gowns missing causing inappropriate fit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22186 |
| MDR Report Key | 22186 |
| Date Received | 1995-05-18 |
| Date of Report | 1995-04-30 |
| Date of Event | 1995-04-21 |
| Date Facility Aware | 1995-04-21 |
| Report Date | 1995-04-30 |
| Date Reported to FDA | 1995-04-30 |
| Date Reported to Mfgr | 1995-04-21 |
| Date Added to Maude | 1995-06-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLATION GOWN |
| Generic Name | ISOLATION GOWN |
| Product Code | FYC |
| Date Received | 1995-05-18 |
| Returned To Mfg | 1995-04-21 |
| Model Number | X-LARGE |
| Lot Number | 1-0438/1-0439 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22285 |
| Manufacturer | MELCO, INC. |
| Manufacturer Address | WILMINGTON DE 19801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-18 |